{"active_ingredient":["Active Ingredients (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg)(NSAID)*"],"dosage_and_administration":["Directions ■ do not take more than directed ■ the smallest effective dose should be used ■ drink a full glass of water with each dose ■ adults and children 12 years and older: take 1 tablet every 8 to 12 hours while symptoms last ■ for the first dose you may take 2 tablets within the first hour ■ do not exceed 2 tablets in any 8 to 12-hour period ■ do not exceed 3 tablets in a 24-hour period ■ Children under 12 years: Ask a doctor"],"effective_time":"20251028","id":"4240708f-eaa2-9c13-e063-6294a90ab632","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline, cellulose, polyethylene glycol, povidone, titanium dioxide"],"indications_and_usage":["Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ common cold ■ muscular aches ■backache ■ toothache ■ menstrual cramps ■minor pain of arthritis ■temporarily reduces fever"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA090545"],"brand_name":["CALMADOL PAIN RELIEVER"],"generic_name":["NAPROXEN SODIUM"],"is_original_packager":[true],"manufacturer_name":["GRANDALL DISTRIBUTING, LLC"],"package_ndc":["48201-007-24"],"product_ndc":["48201-007"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["849574"],"spl_id":["4240708f-eaa2-9c13-e063-6294a90ab632"],"spl_set_id":["8edec8d1-a323-436b-8329-c327438516e3"],"substance_name":["NAPROXEN SODIUM"],"unii":["9TN87S3A3C"]},"other_safety_information":["Other information: Each tablet contains sodium 20 mg. Store at 20-25 C (68-77ºF) Avoid high humidity and excessive heat above 40ºC (104ºF). Keep Carton."],"package_label_principal_display_panel":["Package Labeling CALMADOL PAIN RELIEVER FEVER REDUCER Naproxen Sodium Tablets 220 mg (NSAID) 24 TABLETS CalmadolTabLabel.jpg OuterCarton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purpose Pain reliever/ fever reducer"],"questions":["Questions If you have questions of a medical nature, please conact your pharmacist, doctor or health care professional."],"set_id":"8edec8d1-a323-436b-8329-c327438516e3","spl_product_data_elements":["CALMADOL PAIN RELIEVER Naproxen Sodium HYPROMELLOSES POLYETHYLENE GLYCOL 400 MAGNESIUM STEARATE SILICON DIOXIDE TITANIUM DIOXIDE FD&C BLUE NO. 2 NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM 141"],"spl_unclassified_section":["Distributed by: Grandall Distributing Co., Inc. Glendale, CA 91204-2707"],"version":"7","warnings":["Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ blisters ■ rash If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery Ask a doctor before use if ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have asthma Ask a doctor or pharmacist before use if you are ■ under a doctor's care for any serious condition ■ taking any other drug When using this product ■ take with food or milk if stomach upset occurs ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ redness or swelling is present in the painful area ■ any new symptoms appear"]}